510(k) K193522

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA by Kitazato Corporation — Product Code MQL

K193522 is an FDA 510(k) premarket notification submitted by Kitazato Corporation for the device "iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA". The FDA issued a decision of Substantially Equivalent on August 25, 2020. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Kitazato Corporation has at least 10 other 510(k) clearances on record.